This position serves a critical role in providing supports for the activities/projects in Oncology Business Group (OBG) including clinical studies design, data analysis, as well as publications. In addition, this position will oversee CRO s deliverables and oversee internal contractors, validate analysis datasets and TLGs, and manage timelines of biostatistics deliverables.
Review protocols and interface with clinicians and other functions to understand study requirements and design study elements including sample size calculations, analysis methods, study duration for multiple studies.
Develop and/ or review statistical documents for multiple clinical trials, including SAPs, TLG shells and specifications of variable derivation. Support clinical trial related publications
Provide statistical and validation support for analysis datasets, statistical tables, listings and graphs (TLGs). Perform and validate statistical analysis.
Review CSRs and perform data interpretation.
Work with the internal/CRO statisticians and programmers to ensure the quality of CRO deliverables and on QA of data outputs.
Manage contract statisticians in the group. Provide mentoring and oversee work assigned.
Influence the proper use of statistics in the OBG; contribute to the development of departmental SOPs, standards and guidelines.
Minimum of a Master s degree in Biostatistics or related discipline with at least 8 years of relevant experience in the pharmaceutical industry/CRO environment. PhD preferred (generally with at least 5 years of relevant experience).
Demonstrated excellence in statistical skills across multiple areas of pharmaceutical biostatistics, together with broad understanding and experience of the clinical development process.
Experience with CRO oversight and FDA submission preferred.
Excellent technical writing and verbal communication skills.
Strong teamwork ability/commitment and individual initiative.
Strong organizational skills with ability to effectively manage multiple studies.
Excellent programming skills in SAS or R
Launch your career - Upload your resume now!Upload your resume
Loading some great jobs for you...